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Levomilnacipran extended release may prevent relapse in major depression
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Levomilnacipran extended release, an FDA-approved serotonin and norepinephrine reuptake inhibitor, has the potential to be an effective antidepressant for maintenance treatment and preventing relapse in patients with major depressive disorder, study results indicate.
Also, time to relapse was significantly longer among patients continuing on levomilnacipran (Fetzima, Allergan) extended release (ER) than those taking placebo, according to data published in Depression & Anxiety.
Previously, four short-term randomized, placebo-controlled trials demonstrated the efficacy of levomilnacipran ER and two long-term studies (a 48-week open-label extension study and a 24-week relapse-prevention study) demonstrated its safety, Michael E. Thase, MD, professor of psychiatry with Penn Medicine in the University of Pennsylvania Health System, and colleagues wrote.
In this current relapse-prevention study, Thase and colleagues evaluated the efficacy, safety and tolerability of levomilnacipran ER in preventing relapse in adults with major depression.
The researchers randomly assigned 324 patients who responded to 20 weeks of open-label treatment with levomilnacipran ER at 40 mg, 80 mg or 120 mg per day (8 weeks flexible dosing; 12 weeks fixed dosing) to 26 weeks of double-blind treatment with levomilnacipran ER (same dosage; n = 165) or placebo (n = 159). Time to relapse, defined as insufficient therapeutic response or a Montgomery–Asberg Depression Rating Scale (MADRS) total score of 18 or more at two back-to-back visits, served as the primary endpoint.
The investigators found that relapse occurred in 24.5% of patients in the placebo group and 14.5% of those in the levomilnacipran ER group. Patients who continued to take levomilnacipran ER had a significantly longer time to relapse compared with those who received placebo. The risk for relapse in patients in the placebo group was about twice that of the levomilnacipran ER group (HR = 0.56; 95% CI, 0.33–0.92), analysis revealed.
In addition, post hoc analyses indicated that the time to relapse remained statistically significant in favor of levomilnacipran ER when patients with secondary anxiety disorders were excluded.
By treatment end, the placebo group demonstrated significantly greater increases in MADRS total score, Clinical Global Impression (CGI)-Severity score, Sheehan Disability Scale total and subscale scores than in the levomilnacipran ER group. Furthermore, average CGI-Improvement scores declined significantly less for those receiving placebo than for those receiving levomilnacipran ER.
Overall, 58.8% of levomilnacipran ER patients vs. 56% of placebo patients had treatment-emergent adverse events, 3% vs. 1.3% discontinued treatment due to adverse events, and 1.2% vs. 0.6% had serious adverse events.
“Long-term treatment with levomilnacipran ER was generally safe and well tolerated, and side effects were consistent with those found in shorter studies,” Thase and colleagues wrote. “Collectively, these changes suggest that patients who switched to placebo at randomization had greater worsening of depressive symptoms and functional impairment compared with those who continued treatment with levomilnacipran ER.” – by Savannah Demko
Disclosure: Thase reports many relevant financial disclosures; please see the study for a complete list. The other authors are all full-time employees of Allergan.